Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2) - Full Text View

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT00518687

Purpose

This study assess the efficacy of a single dose of V710 vaccine to prevent serious Staphylococcus aureus infections following elective cardiothoracic surgery. The study will also evaluate the immune response and general safety of the V710 vaccine.

Condition	Intervention	Phase
Staphylococcus Aureus Bacteremia Mediastinitis	Biological: V710 Biological: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery

Further study details as provided by Merck:

Primary Outcome Measures:

Number of participant with Staphylococcus aureus bacteremia [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
Number of participant with Staphylococcus aureus deep sternal wound infections [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
Incidence rate of vaccine-related serious adverse experiences [ Time Frame: Up to 180 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of participants with invasive Staphylococcus aureus infection [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
Number of participants with surgical-site infection [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]

Enrollment:	8032
Study Start Date:	December 2007
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: V710 60 μg	Biological: V710 0.5 ml single injection of V710 (60 μg)
Placebo Comparator: Placebo	Biological: Placebo 0.5 ml single injection of matching placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participant is scheduled to undergo cardiothoracic surgery involving a full median sternotomy within 14 to 60 days after vaccination.
Female participants of reproductive potential are required to have a negative urine or serum pregnancy test immediately prior to study vaccination and must use an acceptable form of birth control.

Exclusion Criteria:

Participants had an invasive Staphylococcus aureus infection within the past 3 months prior to study entry.
A realistic (>50%) possibility that cardiothoracic surgery will be necessary sooner than 10 days after vaccination.
Participant is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery.
Participant has any type of ventricular-assist device in place at the time of study entry.
Participant has a history of anaphylaxis to any of the vaccine components.
Participant received V710 vaccine, any other investigational Staphylococcus aureus vaccine, or investigational Staphylococcus aureus antibodies.
Participant has an oral temperature of ≥100.4ºF (≥38.0ºC) within 48 hours prior to study vaccination.
Participant has impairment of the immune system.
Participant has a medical condition in which the expected survival is less than 90 days.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00518687 History of Changes
Other Study ID Numbers:	V710-003, 2007_523
Study First Received:	August 17, 2007
Last Updated:	October 14, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bacteremia
Mediastinitis
Staphylococcal Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome

Inflammation
Pathologic Processes
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases
Gram-Positive Bacterial Infections

ClinicalTrials.gov processed this record on February 09, 2012